A new systematic review of vitamin D supplements found that daily doses of 10,000 IU/d or bolus doses of up to 600,000 IU were well tolerated in children aged 0-6 years.
Previous research has thoroughly confirmed the impact of vitamin D on skeletal health, as well as other skeletal biological effects.
However, evidence from systematic reviews and meta-analyses regarding the safety of high-dose vitamin D supplementation in early childhood was lacking.
As such, a research team led by Nicklas Brustad, MD, PhD, of the University of Copenhagen, investigated the safety of high-dose vitamin D in children aged 0-6 years and examined the potential clinical side effects and biochemical changes reported in previous studies. . †
The team conducted a systematic review using the PubMed database to identify relevant studies published up to August 24, 2021.
Search terms included “randomized controlled trials”, “child/infant” and “vitamin D”.
Study selection was based on inclusion criteria targeting original RCT, intervention with vitamin D2 or D3 supplementation above 1000 IU/day or bolus therapy, children aged 0 to 6 years, and clinical adverse events and/or biochemical levels of 25 (OH) D, calcium, alkaline phosphatase (ALP), phosphate, parathyroid hormone (PTH) and/or ratio of urinary calcium to creatinine levels (Ca:Cr ratio).
Researchers extracted data on age, race and ethnicity, study participants and intervention details from relevant studies.
Safety outcome data included the proportion of children with 25(OH)D levels greater than 100 ng/mL, hypercalcaemia, abnormal ALP, phosphate, PTH, or Ca:Cr ratios, and clinical and serious adverse events (SAEs).
Finally, reference ranges and comments from eligible studies were used in the categorization of biochemical values as abnormal or within reference ranges.
A total of 32 randomized clinical trials with a total of 8400 study participants were included.
A total of 8 studies with 4612 participants were eligible for meta-analysis and included a control group that received either low-dose vitamin D supplementation (≤400 IU/d) or placebo when investigating the risk of SAEs.
Researchers have not observed an overall increased risk of SAEs in pediatric patients receiving high-dose vitamin D compared to controls (P = 0.89).
In addition, the risk of hypercalcaemia observed in 726 pediatric patients was not increased (P=.51) and clinical adverse events related to vitamin D supplementation were rare.
“The safety results reviewed in this study are clinically relevant and need further investigation because a high dose of vitamin D administered to children appears to have beneficial effects on several health outcomes, such as preventing pneumonia and influenza,” the team wrote. .
The study, “Safety of High-Dose Vitamin D Supplementation in Children 0 to 6 Years of Age,” was published online in JAMA Open Network.
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